Costs for Study Participants. The study drug, study-related procedures, and study visits will be provided at no cost to you. Your Decision to be in the Study Taking part in this study is voluntary. You cannot be forced to be in this study. You may leave the study at any time without penalty or loss of any benefits. Your future medical care will not be affected. The study investigator, Pfizer Inc, or the FDA may take you out of the study without your permission at any time for the following reasons: • You do not follow the instructions of the study investigator • We find out you should not be in the study • The study is stopped • The study becomes harmful to your health • You do not follow the New Haven CRU House Rules If you leave the study or if you are taken out of the study for any reason, you may be asked to return to the CRU for a final visit. You may have some end of study tests at this visit. This is to make sure it is safe for you to leave the study. The data collected to the point of your withdrawal remains part of the study database and may not be removed. If you are withdrawn from the study, or decide to stop the study, you can ask that any unused samples that were collected be destroyed. If you would like to have this done, please contact the study investigator. However, your samples may not be able to be destroyed because: • They may no longer be traceable to you • They may have already been used • They may have been given to a third party New Findings If there is new information about the safety of the study drug or changes in the study tests, we will tell you in a timely manner. You can then decide if you still want to be in the study.
